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FDA 510(k)

HeartFocus (V.1.1.1)

K-Number: K242807 · 2025-04-04

ApplicantDeski
Decision Date2025-04-04
Product CodeQJU
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HeartFocus (V.1.1.1) is a medical device manufactured by Deski. It received FDA 510(k) clearance on 2025-04-04 under approval number K242807. The device is classified under product code QJU. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HeartFocus (V.1.1.1)?

HeartFocus (V.1.1.1) is a medical device that received FDA 510(k) clearance on 2025-04-04. It is manufactured by Deski. The 510(k) number is K242807.

When was HeartFocus (V.1.1.1) approved by the FDA?

HeartFocus (V.1.1.1) received FDA 510(k) clearance on 2025-04-04, under approval number K242807.

What company makes HeartFocus (V.1.1.1)?

HeartFocus (V.1.1.1) is manufactured by Deski.

What is the FDA product code for HeartFocus (V.1.1.1)?

The FDA product code for HeartFocus (V.1.1.1) is QJU.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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